NCT00208260

Intensified Chemotherapy in CRC After Resection of Liver Metastases

Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

Conditions

• Colorectal Cancer
• Liver Metastases
• Chemotherapy

Interventions

Type	Name	Description
DRUG	FOLFIRI	FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
DRUG	FOLFOX-4	FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
DRUG	FOLFIRI-HD	High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
DRUG	FOLFOX-7	FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
DRUG	FOLFIRINOX	FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks

Timeline

• Start date: 2004-04-01
• Completion: 2007-08-01
• First posted: 2005-09-21
• Last updated: 2026-02-05

Locations

1 site across 1 country: France